............... 5 Other Biographical Sketches (Not to exceed four pages for each - See instructions)) ............................ 9 Resources ......................................................................................................................................................... 19 Research Plan Introduction to Revised Application (Not to exceed 3 pages) ................................................................................................................ Introduction to Supplemental Application (Not to exceed one page) .................................................................................................... A. Specific Aims ............................................................................. _ ....................................................................... :................. 20 / r-- B. Background and Significance ........................................................ I"........................................................................................ I'" C. Preliminary Studies/Progress Report/ _.- (Items A-D: not to exceed 25 pages*) ._ Phase I Progress Report (SBIPJSTTR Phase II ONLY) I* SBIR/STTR Phase I: Items A-D limited to 15 pages. I I I D. Research Design and Methods ............................................... _ ......................................................................................... E. Human Subjects .......................................................................................................................................................................... Protection of Human Subjects (Required if Item 4 on the Face Page is marked "Yes") Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes") ...................................................................... Inclusion of Minorities (Required if Item 4 on the Face Page is marked "Yes") .................................................................... Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") ...................................................................... Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked "Yes" and a Phase I, II, or III clinical trial is proposed ............................................................................................................................................................... F. Vertebrate Animals ..................................................................................................................................................................... G. Literature Cited ............................................................................................................................................................................ H. Consortium/Contractual Arrangements ...................................................................................................................................... I. Consultants ................................................................................................................................................................................. J. Product Development Plan (SBIR/STTR Phase II and Fast-Track ONLY) ............................................................................... Checklist .......................................................... ................................................................................................. Appendix (Five collated sets. No page numbering necessary for Appendix.) Check if Appendix is Included Appendices NOT PERMITTED for Phase I SBIR/S TTR unless specifically solicited. Number of publicaEExis and manusoripts acoepted for publication (not to exceed 10) 10 Other items (list):